V-LoX Knotless DEX 11262

GUDID M685112620

4.75 x 15 V-LoX Knotless DEX Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device IDM685112620
NIH Device Record Key1419f63b-1dd8-42ad-bcdb-a5ffc39e19bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-LoX Knotless DEX
Version Model Number11262
Catalog Number11262
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone941-755-7965
EmailCustomerService@ParcusMedical.com

Device Dimensions

Outer Diameter4.75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM685112620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-31
Device Publish Date2019-10-23

On-Brand Devices [V-LoX Knotless DEX]

M6851126305.5 x 15 V-LoX Knotless DEX Suture Anchor
M6851126204.75 x 15 V-LoX Knotless DEX Suture Anchor

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